Efficacy and safety of sitagliptin added to metformin and insulin compared with voglibose in patients with newly diagnosed type 2 diabetes
Clinics
;
74: e736, 2019. tab, graf
Artículo
en Inglés
| LILACS
| ID: biblio-1001839
ABSTRACT
OBJECTIVE:
To assess the efficacy and safety of sitagliptin compared with voglibose added to combined metformin and insulin in patients with newly diagnosed type 2 diabetes (T2DM).METHODS:
In this 12-week prospective, randomized, parallel trial, 70 newly diagnosed T2DM patients with glycosylated hemoglobin (HbA1c) ≥9% and/or fasting plasma glucose (FPG) ≥11.1 mmol/L were randomized (11) to receive sitagliptin 100 mg per day + metformin + insulin glargine or voglibose 0.2 mg three times daily + metformin + insulin glargine. Change in HbA1c at week 12 was the primary endpoint.RESULTS:
The mean baseline HbA1c was 11.0% in the patients. The changes in HbA1c from baseline were -6.00% in the sitagliptin group and -3.58% in the voglibose group, and the between-group difference was -2.42% (95% CI -1.91 to -2.93, p=0.02). The differences in FPG and homeostatic model assessment of β-cell function (HOMA-β) and the change in body weight between groups from baseline were -2.95 mmol/L (p=0.04), 43.91 (p=0.01) and -2.23 kg (p=0.01), respectively. One patient (2.9%) in the sitagliptin group and three patients (8.6%) in the voglibose group exhibited hypoglycemia.CONCLUSIONS:
Sitagliptin added to combined metformin and insulin therapy showed greater efficacy and good safety regarding hypoglycemia in patients with newly diagnosed T2DM compared with voglibose.
Texto completo:
Disponible
Índice:
LILACS (Américas)
Asunto principal:
Diabetes Mellitus Tipo 2
/
Fosfato de Sitagliptina
/
Hipoglucemiantes
/
Inositol
/
Metformina
Tipo de estudio:
Ensayo Clínico Controlado
/
Estudio diagnóstico
/
Estudio observacional
Límite:
Adulto
/
Anciano
/
Femenino
/
Humanos
/
Masculino
Idioma:
Inglés
Revista:
Clinics
Asunto de la revista:
Medicina
Año:
2019
Tipo del documento:
Artículo
País de afiliación:
China
Institución/País de afiliación:
Dalian Medical University/CN
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